Opening for M.Pharm Graduates as Officer / Executive - Regulatory Affairs - API @ Sun Pharma
JOB DESCRIPTION
1. Preparation and Execution of Drug Master files of API in
CTD and ECTD format, independently in coordination with plant people.
2. Checking and reviewing of documents required for DMF
filing received from plant for its thoroughness and getting corrections done
from plant, independently.
3. Handling to DMF deficiencies Preparation of action plan
and deficiency responses Timely Response of DMF deficiencies in coordination
from R&D, Plant , ADD
4. Annual updates of DMF and renewal applications for CEP .
5. Completion of QA and ISO questionnaire received from
customers in coordination with plants.
6. Helping API plants for the preparation of audits from
Regulatory Agencies, in case required.
7. Moving to API locations for checking and collection of
documents as and when required
DESIRED SKILLS AND EXPERIENCE
Qualification - Bsc, Msc, Mpharm
Experience - 4 to 9 years of experience in API Regulatory
Affairs